Cleared Traditional

K091579 - FORESEE HOME

K091579 is an FDA 510(k) clearance for FORESEE HOME, manufactured by Notal Vision , Ltd.. The device is a Class 1 Ophthalmic device with product code HPT cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K091579 · Notal Vision , Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
204d
Days
Class 1
Risk

K091579 is an FDA 510(k) clearance for the FORESEE HOME. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Notal Vision , Ltd. (Laguna Beach, US). The FDA issued a Cleared decision on December 23, 2009 after a review of 204 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K091579

510(k) Number K091579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2009
Decision Date December 23, 2009
Days to Decision 204 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 110d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

HPT Device Classification - Class 1, General Controls

Product Code HPT Perimeter, Automatic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Clinical Evidence

ClinicalTrials.gov
NCT00776451 Completed Observational Industry-sponsored

Usability of the PreView PHP for Home Use in Intermediate AMD Patients

Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients

66
Patients (est.)
1
Site
Condition studied Age Related Macular Degeneration
Eligibility All sexes · 65 Years+
Principal investigator Neil Bressler, Prof.
Sponsor Notal Vision Ltd. (industry)
Started 2008-11-01 → Primary completion 2009-02-01 → Completed 2009-03-01
Primary outcome
The proportion of subjects who successfully completed the test by themselves, in a home simulated environment
Study completed - no results published. This trial concluded in 2009 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - HPT Perimeter, Automatic, Ac-powered

All 26
Devices cleared under the same product code (HPT) and FDA review panel - the closest regulatory comparables to K091579.
MAIA, MODEL 1
K092187 · Centervue S.P.A. · May 2010
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
K093213 · Carl Zeiss Meditec, Inc. · Mar 2010
TRUEFIELD ANALYZER
K063310 · Seeing Machines Limited · Aug 2007
THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)
K050350 · Notal Vision, Inc. · Apr 2005
NOVAVISION, MODEL 2.0
K023623 · Novavision, Inc. · Apr 2003
KASHA VISUAL FIELD SYSTEM
K971156 · Kasha Software, Inc. · May 1997
K091579 · FORESEE HOME
Download PDF FDA Summary Notal Vision , Ltd.